Free GAQM ISO-QMS-13485 Exam Questions
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GAQM ISO-QMS-13485 Exam Questions
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Provided By: GAQM
- Exam: ISO 13485:2016 - Certified Lead Auditor
- Certification: GAQM ISO
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Total Questions: 300
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Updated On: Jun 03, 2025
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Rated: 4.9 |
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Online Users: 600
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Question 1
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A medical device company uses a commercial off-the-shelf (COTS) software program for managing its training records. The software is not directly used in the manufacturing process but is integral to personnel training and demonstrating compliance with ISO 13485:2016. The Lead Auditor reviews the company's training procedure and notes the procedure indicates the company must perform testing of software used within the QMS, and validation is not required. Which of the following would be the MOST appropriate determination for the Lead Auditor?
Answer: D
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A medical device company uses a commercial off-the-shelf (COTS) software program for managing its training records. The software is not directly used in the manufacturing process but is integral to personnel training and demonstrating compliance with ISO 13485:2016. The Lead Auditor reviews the company's training procedure and notes the procedure indicates the company must perform testing of software used within the QMS, and validation is not required. Which of the following would be the MOST appropriate determination for the Lead Auditor?
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Question 2
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A medical device company is undergoing an ISO 13485:2016 audit. The company has a documented procedure for supplier evaluation, and the company has several suppliers used to produce critical components. The company’s procedure outlines initial evaluation, periodic evaluation, and performance monitoring, however, for some suppliers that are deemed “low-risk” there is no *documented rationale* for why those suppliers were classified as such. As the Lead Auditor, what is the MOST appropriate action to take?
Answer: B
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A medical device company is undergoing an ISO 13485:2016 audit. The company has a documented procedure for supplier evaluation, and the company has several suppliers used to produce critical components. The company’s procedure outlines initial evaluation, periodic evaluation, and performance monitoring, however, for some suppliers that are deemed “low-risk” there is no *documented rationale* for why those suppliers were classified as such. As the Lead Auditor, what is the MOST appropriate action to take?
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Question 3
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A medical device company utilizes a cloud-based platform for managing its Quality Management System (QMS) documentation. The company’s documented procedure for software validation and data security, while comprehensive, does not address the specific requirements for verifying the ongoing data integrity and availability of QMS data on the cloud platform. The company does not perform independent backup of their cloud data. As a Lead Auditor, what is the MOST appropriate action to take?
Answer: C
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A medical device company utilizes a cloud-based platform for managing its Quality Management System (QMS) documentation. The company’s documented procedure for software validation and data security, while comprehensive, does not address the specific requirements for verifying the ongoing data integrity and availability of QMS data on the cloud platform. The company does not perform independent backup of their cloud data. As a Lead Auditor, what is the MOST appropriate action to take?
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Question 4
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A medical device company is undergoing an ISO 13485:2016 audit. The company has a documented procedure for supplier evaluation, and the company has several suppliers used to produce critical components. The company’s procedure outlines initial evaluation, periodic evaluation, and performance monitoring, however, for some suppliers that are deemed “low-risk” there is no *documented rationale* for why those suppliers were classified as such. As the Lead Auditor, what is the MOST appropriate action to take?
Answer: B
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A medical device company is undergoing an ISO 13485:2016 audit. The company has a documented procedure for supplier evaluation, and the company has several suppliers used to produce critical components. The company’s procedure outlines initial evaluation, periodic evaluation, and performance monitoring, however, for some suppliers that are deemed “low-risk” there is no *documented rationale* for why those suppliers were classified as such. As the Lead Auditor, what is the MOST appropriate action to take?
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Question 5
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A medical device company manufactures Class IIa devices and is undergoing an ISO 13485:2016 audit. The company performs internal audits. The Lead Auditor reviews the internal audit reports and discovers that the reports consistently lack objective evidence to support the audit findings and conclusions. The Quality Manager explains that while the audit reports may not contain direct objective evidence in the report, they maintain detailed working papers with all the objective evidence, that can be requested and reviewed upon request, and which support the report's findings. What should be the Lead Auditor's MOST appropriate course of action?
Answer: C
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A medical device company manufactures Class IIa devices and is undergoing an ISO 13485:2016 audit. The company performs internal audits. The Lead Auditor reviews the internal audit reports and discovers that the reports consistently lack objective evidence to support the audit findings and conclusions. The Quality Manager explains that while the audit reports may not contain direct objective evidence in the report, they maintain detailed working papers with all the objective evidence, that can be requested and reviewed upon request, and which support the report's findings. What should be the Lead Auditor's MOST appropriate course of action?